Medical Director/Senior Medical Director

Massachusetts
4742
Our client is a clinical-stage pharmaceutical company. They have asked us to assist them in their search for a Medical Director/Senior Medical Director.  

Major tasks and responsibilities will include:
  • Provides clinical leadership and strategic medical input for all clinical deliverables, including clinical development plans, for critical projects and clinical programs.
  • Collaborates with physician, scientists, regulatory professionals (etc.), to develop and execute clinical trials from beginning to end.
  • Assumes medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and safety data review.
  • Develops deep understanding of the clinical and competitive environment and works with teams to develop target product profiles for projects in both research and development.
  • Partners with clinical operations and PV on clinical trial conduct and monitoring, including GCP, patient eligibility, safety monitoring, AE and SAE tracking and reporting, and protocol deviations.
  • Participates in regulatory authority interactions, as necessary.
  • Provides medical oversight and clinical guidance into regulatory submissions, clinical protocols, investigator brochures, informed consent forms, and clinical study reports.
 
We seek candidates with the following qualifications:
  • Medical degree with postgraduate training/certification/fellowship in hematology/oncology required. Will consider someone with a broader training that has experience with hematologic malignancies.
  • A minimum of 3 years of experience in clinical development in the pharmaceutical/biotech industries is highly preferred.
  • Requires thorough understanding of GCP and international regulations applicable to clinical development.
  • Must have a successful track record of designing and interpreting development plans and clinical studies.
  • The ability to review and understand the emerging safety and efficacy profile of the drug candidate is required.
  • Experience with development of immune-oncology therapeutics highly preferred.
  • Must have the demonstrated ability to present clinical data, study plans, and tactics clearly and accurately to internal and external stakeholders.
  • Excellent communication skills required.
  • Requires a high degree of accuracy and attention to detail with a focus on driving quality results.
  • Good judgement/analytical thinking capabilities required.
   
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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